Trial Outcomes & Findings for Responses to Regulated E-Cigarette Advertisements (NCT NCT05207033)

NCT ID: NCT05207033

Last Updated: 2025-05-30

Results Overview

Use of any tobacco products

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

195 participants

Primary outcome timeframe

1 month

Results posted on

2025-05-30

Participant Flow

Enrollment was N=195, however, prior to assignment, 9 participants stopped responding to communications from study staff including the initial survey, and thus were never assigned to a arm/group.

Participant milestones

Participant milestones
Measure
Unregulated ad Condition
This arm will include exposure to unregulated e-cigarette ads or ads as they appear in modern media. Unregulated ad condition: This intervention will determine if unrestricted appealing features in e-cigarette ads deter young adults from trying the product.
Regulated ad Condition
This arm will include exposure to regulated e-cigarette ads or ads where we have taken out the appealing features. Regulated ad condition: This intervention will determine if restriction of appealing features in e-cigarette ads deter young adults from trying the product.
Overall Study
STARTED
94
92
Overall Study
COMPLETED
88
84
Overall Study
NOT COMPLETED
6
8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Responses to Regulated E-Cigarette Advertisements

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Unregulated ad Condition
n=88 Participants
This arm will include exposure to unregulated e-cigarette ads or ads as they appear in modern media. Unregulated ad condition: This intervention will determine if unrestricted appealing features in e-cigarette ads deter young adults from trying the product.
Regulated ad Condition
n=84 Participants
This arm will include exposure to regulated e-cigarette ads or ads where we have taken out the appealing features. Regulated ad condition: This intervention will determine if restriction of appealing features in e-cigarette ads deter young adults from trying the product.
Total
n=172 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Age, Categorical
Between 18 and 65 years
88 Participants
n=99 Participants
84 Participants
n=107 Participants
172 Participants
n=206 Participants
Age, Categorical
>=65 years
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Age, Continuous
22.13 years
STANDARD_DEVIATION 2.32 • n=99 Participants
22.88 years
STANDARD_DEVIATION 2.54 • n=107 Participants
22.5 years
STANDARD_DEVIATION 2.46 • n=206 Participants
Sex/Gender, Customized
female
67 Participants
n=99 Participants
69 Participants
n=107 Participants
136 Participants
n=206 Participants
Sex/Gender, Customized
male
16 Participants
n=99 Participants
13 Participants
n=107 Participants
29 Participants
n=206 Participants
Sex/Gender, Customized
other
5 Participants
n=99 Participants
2 Participants
n=107 Participants
7 Participants
n=206 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Asian
7 Participants
n=99 Participants
18 Participants
n=107 Participants
25 Participants
n=206 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Black or African American
1 Participants
n=99 Participants
8 Participants
n=107 Participants
9 Participants
n=206 Participants
Race (NIH/OMB)
White
57 Participants
n=99 Participants
44 Participants
n=107 Participants
101 Participants
n=206 Participants
Race (NIH/OMB)
More than one race
7 Participants
n=99 Participants
10 Participants
n=107 Participants
17 Participants
n=206 Participants
Race (NIH/OMB)
Unknown or Not Reported
16 Participants
n=99 Participants
4 Participants
n=107 Participants
20 Participants
n=206 Participants
Region of Enrollment
United States
88 participants
n=99 Participants
84 participants
n=107 Participants
171 participants
n=206 Participants

PRIMARY outcome

Timeframe: 1 month

Use of any tobacco products

Outcome measures

Outcome measures
Measure
Unregulated ad Condition
n=87 Participants
This arm will include exposure to unregulated e-cigarette ads or ads as they appear in modern media. Unregulated ad condition: This intervention will determine if unrestricted appealing features in e-cigarette ads deter young adults from trying the product.
Regulated ad Condition
n=84 Participants
This arm will include exposure to regulated e-cigarette ads or ads where we have taken out the appealing features. Regulated ad condition: This intervention will determine if restriction of appealing features in e-cigarette ads deter young adults from trying the product.
Tobacco Use at 1 Month
5 Participants
5 Participants

PRIMARY outcome

Timeframe: 3 months

Use of any tobacco products

Outcome measures

Outcome measures
Measure
Unregulated ad Condition
n=87 Participants
This arm will include exposure to unregulated e-cigarette ads or ads as they appear in modern media. Unregulated ad condition: This intervention will determine if unrestricted appealing features in e-cigarette ads deter young adults from trying the product.
Regulated ad Condition
n=84 Participants
This arm will include exposure to regulated e-cigarette ads or ads where we have taken out the appealing features. Regulated ad condition: This intervention will determine if restriction of appealing features in e-cigarette ads deter young adults from trying the product.
Tobacco Use at 3 Months
3 Participants
2 Participants

PRIMARY outcome

Timeframe: 6 months

Use of any tobacco products

Outcome measures

Outcome measures
Measure
Unregulated ad Condition
n=87 Participants
This arm will include exposure to unregulated e-cigarette ads or ads as they appear in modern media. Unregulated ad condition: This intervention will determine if unrestricted appealing features in e-cigarette ads deter young adults from trying the product.
Regulated ad Condition
n=84 Participants
This arm will include exposure to regulated e-cigarette ads or ads where we have taken out the appealing features. Regulated ad condition: This intervention will determine if restriction of appealing features in e-cigarette ads deter young adults from trying the product.
Tobacco Use at 6 Months
1 Participants
2 Participants

PRIMARY outcome

Timeframe: 1 month

Perceived severity of using e-cigarettes, a subconstruct of the Health Belief Model was assessed by participants' perceived significance, severity, and seriousness of health threats from e-cigarette use. The measure is as follows in its exact and unabbreviated form: Please rate the following statements on a scale from 1 (strongly disagree) to 5 (strongly agree). I believe that the health threat of using e-cigarettes is severe. I believe that the health threat of using e-cigarettes is serious. I believe that the health threat of using e-cigarettes is significant. To determine score, the average is taken of the items. Minimum Score = 1; Maximum Score = 5 Higher scores indicate greater perceived severity of e-cigarette use. Lower scores indicate lesser perceived severity of e-cigarette use.

Outcome measures

Outcome measures
Measure
Unregulated ad Condition
n=87 Participants
This arm will include exposure to unregulated e-cigarette ads or ads as they appear in modern media. Unregulated ad condition: This intervention will determine if unrestricted appealing features in e-cigarette ads deter young adults from trying the product.
Regulated ad Condition
n=84 Participants
This arm will include exposure to regulated e-cigarette ads or ads where we have taken out the appealing features. Regulated ad condition: This intervention will determine if restriction of appealing features in e-cigarette ads deter young adults from trying the product.
Perceived Severity of Using E-Cigarettes at 1 Month
4.41 units on a scale
Standard Deviation .66
4.46 units on a scale
Standard Deviation .61

PRIMARY outcome

Timeframe: 3 months

Perceived severity of using e-cigarettes, a subconstruct of the Health Belief Model was assessed by participants' perceived significance, severity, and seriousness of health threats from e-cigarette use. The measure is as follows in its exact and unabbreviated form: Please rate the following statements on a scale from 1 (strongly disagree) to 5 (strongly agree). I believe that the health threat of using e-cigarettes is severe. I believe that the health threat of using e-cigarettes is serious. I believe that the health threat of using e-cigarettes is significant. To determine score, the average is taken of the items. Minimum Score = 1; Maximum Score = 5 Higher scores indicate greater perceived severity of e-cigarette use. Lower scores indicate lesser perceived severity of e-cigarette use.

Outcome measures

Outcome measures
Measure
Unregulated ad Condition
n=87 Participants
This arm will include exposure to unregulated e-cigarette ads or ads as they appear in modern media. Unregulated ad condition: This intervention will determine if unrestricted appealing features in e-cigarette ads deter young adults from trying the product.
Regulated ad Condition
n=84 Participants
This arm will include exposure to regulated e-cigarette ads or ads where we have taken out the appealing features. Regulated ad condition: This intervention will determine if restriction of appealing features in e-cigarette ads deter young adults from trying the product.
Perceived Severity of Using E-Cigarettes at 3 Months
4.41 units on a scale
Standard Deviation .67
4.36 units on a scale
Standard Deviation .71

PRIMARY outcome

Timeframe: 6 months

Perceived severity of using e-cigarettes, a subconstruct of the Health Belief Model was assessed by participants' perceived significance, severity, and seriousness of health threats from e-cigarette use. The measure is as follows in its exact and unabbreviated form: Please rate the following statements on a scale from 1 (strongly disagree) to 5 (strongly agree). I believe that the health threat of using e-cigarettes is severe. I believe that the health threat of using e-cigarettes is serious. I believe that the health threat of using e-cigarettes is significant. To determine score, the average is taken of the items. Minimum Score = 1; Maximum Score = 5 Higher scores indicate greater perceived severity of e-cigarette use. Lower scores indicate lesser perceived severity of e-cigarette use.

Outcome measures

Outcome measures
Measure
Unregulated ad Condition
n=87 Participants
This arm will include exposure to unregulated e-cigarette ads or ads as they appear in modern media. Unregulated ad condition: This intervention will determine if unrestricted appealing features in e-cigarette ads deter young adults from trying the product.
Regulated ad Condition
n=84 Participants
This arm will include exposure to regulated e-cigarette ads or ads where we have taken out the appealing features. Regulated ad condition: This intervention will determine if restriction of appealing features in e-cigarette ads deter young adults from trying the product.
Perceived Severity of Using E-Cigarettes at 6 Months
4.48 units on a scale
Standard Deviation .63
4.48 units on a scale
Standard Deviation .59

PRIMARY outcome

Timeframe: 1 Month

Motivation to avoid e-cigarettes was assessed by participants' self-reported importance, confidence, readiness, and commitment to avoid e-cigarette use in the future. These items reflect constructs from behavior change theories such as the Transtheoretical Model, which emphasizes individual readiness and self-efficacy as key predictors of behavioral intention and action. The measure is as follows in its exact and unabbreviated form: Please rate the following statements on a scale from 0 to 10. 0 = Not at all 10 = Very How important is it to avoid e-cigarettes in the future? How confident are you in avoiding e-cigarettes in the future? How ready are you to avoid e-cigarettes in the future? How committed are you to avoid e-cigarettes in the future? To determine score, the average is taken across the four items. Minimum Score = 0; Maximum Score = 10 Higher scores indicate greater motivation to avoid e-cigarette use. Lower scores indicate lesser motivation.

Outcome measures

Outcome measures
Measure
Unregulated ad Condition
n=87 Participants
This arm will include exposure to unregulated e-cigarette ads or ads as they appear in modern media. Unregulated ad condition: This intervention will determine if unrestricted appealing features in e-cigarette ads deter young adults from trying the product.
Regulated ad Condition
n=84 Participants
This arm will include exposure to regulated e-cigarette ads or ads where we have taken out the appealing features. Regulated ad condition: This intervention will determine if restriction of appealing features in e-cigarette ads deter young adults from trying the product.
Motivation to Avoid E-Cigarettes at 1 Month
7.66 score on a scale
Standard Deviation 2.03
8.05 score on a scale
Standard Deviation 1.89

PRIMARY outcome

Timeframe: 3 Months

Motivation to avoid e-cigarettes was assessed by participants' self-reported importance, confidence, readiness, and commitment to avoid e-cigarette use in the future. These items reflect constructs from behavior change theories such as the Transtheoretical Model, which emphasizes individual readiness and self-efficacy as key predictors of behavioral intention and action. The measure is as follows in its exact and unabbreviated form: Please rate the following statements on a scale from 0 to 10. 0 = Not at all 10 = Very How important is it to avoid e-cigarettes in the future? How confident are you in avoiding e-cigarettes in the future? How ready are you to avoid e-cigarettes in the future? How committed are you to avoid e-cigarettes in the future? To determine score, the average is taken across the four items. Minimum Score = 0; Maximum Score = 10 Higher scores indicate greater motivation to avoid e-cigarette use. Lower scores indicate lesser motivation.

Outcome measures

Outcome measures
Measure
Unregulated ad Condition
n=87 Participants
This arm will include exposure to unregulated e-cigarette ads or ads as they appear in modern media. Unregulated ad condition: This intervention will determine if unrestricted appealing features in e-cigarette ads deter young adults from trying the product.
Regulated ad Condition
n=84 Participants
This arm will include exposure to regulated e-cigarette ads or ads where we have taken out the appealing features. Regulated ad condition: This intervention will determine if restriction of appealing features in e-cigarette ads deter young adults from trying the product.
Motivation to Avoid E-Cigarettes at 3 Months
7.74 score on a scale
Standard Deviation 2.13
8.02 score on a scale
Standard Deviation 1.87

PRIMARY outcome

Timeframe: 6 Months

Motivation to avoid e-cigarettes was assessed by participants' self-reported importance, confidence, readiness, and commitment to avoid e-cigarette use in the future. These items reflect constructs from behavior change theories such as the Transtheoretical Model, which emphasizes individual readiness and self-efficacy as key predictors of behavioral intention and action. The measure is as follows in its exact and unabbreviated form: Please rate the following statements on a scale from 0 to 10. 0 = Not at all 10 = Very How important is it to avoid e-cigarettes in the future? How confident are you in avoiding e-cigarettes in the future? How ready are you to avoid e-cigarettes in the future? How committed are you to avoid e-cigarettes in the future? To determine score, the average is taken across the four items. Minimum Score = 0; Maximum Score = 10 Higher scores indicate greater motivation to avoid e-cigarette use. Lower scores indicate lesser motivation.

Outcome measures

Outcome measures
Measure
Unregulated ad Condition
n=87 Participants
This arm will include exposure to unregulated e-cigarette ads or ads as they appear in modern media. Unregulated ad condition: This intervention will determine if unrestricted appealing features in e-cigarette ads deter young adults from trying the product.
Regulated ad Condition
n=84 Participants
This arm will include exposure to regulated e-cigarette ads or ads where we have taken out the appealing features. Regulated ad condition: This intervention will determine if restriction of appealing features in e-cigarette ads deter young adults from trying the product.
Motivation to Avoid E-Cigarettes at 6 Months
7.87 score on a scale
Standard Deviation 2.08
8.00 score on a scale
Standard Deviation 1.87

PRIMARY outcome

Timeframe: 1 month

Behavioral intentions to use e-cigarettes were assessed using participants' self-reported interest and willingness to engage in future e-cigarette use. This construct is grounded in the Theory of Planned Behavior, which identifies behavioral intention as the most immediate and reliable predictor of future behavior. The measure is as follows in its exact and unabbreviated form: How interested are you in trying e-cigarettes? How willing are you to try e-cigarettes? How willing would you be to purchase an e-cigarette? How willing would you be to try an e-cigarette if a friend offered you one? Responses were rated on a scale from 1 (not at all) to 5 (very). To determine score, the average is taken across the four items. Minimum Score = 1; Maximum Score = 5 Higher scores indicate stronger behavioral intentions to use e-cigarettes. Lower scores indicate weaker intentions.

Outcome measures

Outcome measures
Measure
Unregulated ad Condition
n=87 Participants
This arm will include exposure to unregulated e-cigarette ads or ads as they appear in modern media. Unregulated ad condition: This intervention will determine if unrestricted appealing features in e-cigarette ads deter young adults from trying the product.
Regulated ad Condition
n=84 Participants
This arm will include exposure to regulated e-cigarette ads or ads where we have taken out the appealing features. Regulated ad condition: This intervention will determine if restriction of appealing features in e-cigarette ads deter young adults from trying the product.
Behavioral Intentions at 1 Month
3.23 score on a scale
Standard Deviation .76
3.32 score on a scale
Standard Deviation .76

PRIMARY outcome

Timeframe: 3 months

Behavioral intentions to use e-cigarettes were assessed using participants' self-reported interest and willingness to engage in future e-cigarette use. This construct is grounded in the Theory of Planned Behavior, which identifies behavioral intention as the most immediate and reliable predictor of future behavior. The measure is as follows in its exact and unabbreviated form: How interested are you in trying e-cigarettes? How willing are you to try e-cigarettes? How willing would you be to purchase an e-cigarette? How willing would you be to try an e-cigarette if a friend offered you one? Responses were rated on a scale from 1 (not at all) to 5 (very). To determine score, the average is taken across the four items. Minimum Score = 1; Maximum Score = 5 Higher scores indicate stronger behavioral intentions to use e-cigarettes. Lower scores indicate weaker intentions.

Outcome measures

Outcome measures
Measure
Unregulated ad Condition
n=87 Participants
This arm will include exposure to unregulated e-cigarette ads or ads as they appear in modern media. Unregulated ad condition: This intervention will determine if unrestricted appealing features in e-cigarette ads deter young adults from trying the product.
Regulated ad Condition
n=84 Participants
This arm will include exposure to regulated e-cigarette ads or ads where we have taken out the appealing features. Regulated ad condition: This intervention will determine if restriction of appealing features in e-cigarette ads deter young adults from trying the product.
Behavioral Intentions at 3 Months
3.19 score on a scale
Standard Deviation .83
3.37 score on a scale
Standard Deviation .80

PRIMARY outcome

Timeframe: 6 months

Behavioral intentions to use e-cigarettes were assessed using participants' self-reported interest and willingness to engage in future e-cigarette use. This construct is grounded in the Theory of Planned Behavior, which identifies behavioral intention as the most immediate and reliable predictor of future behavior. The measure is as follows in its exact and unabbreviated form: How interested are you in trying e-cigarettes? How willing are you to try e-cigarettes? How willing would you be to purchase an e-cigarette? How willing would you be to try an e-cigarette if a friend offered you one? Responses were rated on a scale from 1 (not at all) to 5 (very). To determine score, the average is taken across the four items. Minimum Score = 1; Maximum Score = 5 Higher scores indicate stronger behavioral intentions to use e-cigarettes. Lower scores indicate weaker intentions.

Outcome measures

Outcome measures
Measure
Unregulated ad Condition
n=87 Participants
This arm will include exposure to unregulated e-cigarette ads or ads as they appear in modern media. Unregulated ad condition: This intervention will determine if unrestricted appealing features in e-cigarette ads deter young adults from trying the product.
Regulated ad Condition
n=84 Participants
This arm will include exposure to regulated e-cigarette ads or ads where we have taken out the appealing features. Regulated ad condition: This intervention will determine if restriction of appealing features in e-cigarette ads deter young adults from trying the product.
Behavioral Intentions at 6 Months
3.24 score on a scale
Standard Deviation .75
3.20 score on a scale
Standard Deviation .88

PRIMARY outcome

Timeframe: 1 month

Biochemical confirmation of tobacco use was conducted using the Alere iScreen Oral Fluid Device (OFD), a point-of-care saliva test that detects cotinine, a primary metabolite of nicotine, indicating tobacco or nicotine product use within the past \~3 days. The count reflects participants who tested positive for cotinine, providing biochemical evidence of recent tobacco or nicotine exposure.

Outcome measures

Outcome measures
Measure
Unregulated ad Condition
n=87 Participants
This arm will include exposure to unregulated e-cigarette ads or ads as they appear in modern media. Unregulated ad condition: This intervention will determine if unrestricted appealing features in e-cigarette ads deter young adults from trying the product.
Regulated ad Condition
n=84 Participants
This arm will include exposure to regulated e-cigarette ads or ads where we have taken out the appealing features. Regulated ad condition: This intervention will determine if restriction of appealing features in e-cigarette ads deter young adults from trying the product.
Number of Participants With Biochemical Verification of Tobacco Use at 1 Month
0 Participants
1 Participants

PRIMARY outcome

Timeframe: 3 months

Biochemical confirmation of tobacco use was conducted using the Alere iScreen Oral Fluid Device (OFD), a point-of-care saliva test that detects cotinine, a primary metabolite of nicotine, indicating tobacco or nicotine product use within the past \~3 days. The count reflects participants who tested positive for cotinine, providing biochemical evidence of recent tobacco or nicotine exposure.

Outcome measures

Outcome measures
Measure
Unregulated ad Condition
n=87 Participants
This arm will include exposure to unregulated e-cigarette ads or ads as they appear in modern media. Unregulated ad condition: This intervention will determine if unrestricted appealing features in e-cigarette ads deter young adults from trying the product.
Regulated ad Condition
n=84 Participants
This arm will include exposure to regulated e-cigarette ads or ads where we have taken out the appealing features. Regulated ad condition: This intervention will determine if restriction of appealing features in e-cigarette ads deter young adults from trying the product.
Number of Participants With Biochemical Verification of Tobacco Use at 3 Months
1 Participants
2 Participants

PRIMARY outcome

Timeframe: 6 months

Biochemical confirmation of tobacco use was conducted using the Alere iScreen Oral Fluid Device (OFD), a point-of-care saliva test that detects cotinine, a primary metabolite of nicotine, indicating tobacco or nicotine product use within the past \~3 days. The count reflects participants who tested positive for cotinine, providing biochemical evidence of recent tobacco or nicotine exposure.

Outcome measures

Outcome measures
Measure
Unregulated ad Condition
n=87 Participants
This arm will include exposure to unregulated e-cigarette ads or ads as they appear in modern media. Unregulated ad condition: This intervention will determine if unrestricted appealing features in e-cigarette ads deter young adults from trying the product.
Regulated ad Condition
n=84 Participants
This arm will include exposure to regulated e-cigarette ads or ads where we have taken out the appealing features. Regulated ad condition: This intervention will determine if restriction of appealing features in e-cigarette ads deter young adults from trying the product.
Number of Participants With Biochemical Verification of Tobacco Use at 6 Months
0 Participants
3 Participants

Adverse Events

Unregulated ad Condition

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Regulated ad Condition

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Elise Stevens, Assistant Professor

University of Massachusetts Chan Medical School

Phone: (774) 455-6684

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place